Component Preparation / Autoclave Operator

Role & responsibilities

1. Follow the gowning procedure and maintain general hygiene in the component/compounding preparation area.

2. Affix the proper status labeling on materials, areas, and equipment.

3. Responsible for line clearance of the component or batch preparation area no abnormalities or deviations shall be observed during the line clearance process.

4. Ensure the all utilities shall be available prior to start of the autoclave operation

5. Involve in the installation, commissioning, and qualification of steam sterilizers and any other equipment and accessories.

6. Perform cleaning of manufacturing accessories, vessels, filtration items, and filling items.

7. Perform autoclave load preparation as per validated load patterns.

8. Operate and monitor steam sterilizers (autoclaves) and pressure hold test equipment as per standard operating procedures.

9. Indent, receipt, and inspect production consumables like tubing, filters, gloves, garments, and gaskets.

10. Transfer dispensed consumable items from the warehouse to production areas.

11. Operations include verification and maintenance of validated load parameters and load patterns.

12. Transfer and receipt of change parts from APA for cleaning and sterilization as per SOP.

13. Requisition and receipt of GMP documents, load patterns, logbooks, and BMRs from QA.

14. Ensure the timely submission of filled logbooks and other Good Manufacturing Practice (GMP) documents to quality assurance.

15. Follow production schedules and work orders to achieve daily objectives.

16. Clean work area according to safety and hygiene standards.

17. Perform integrity testing and replacement of vent filters as per SOP.

18. Monitor equipment faults and report major issues to maintenance personnel, if required.

19. Record production data, including input quantities and quality control results.

20. Collaborate with colleagues to ensure a smooth workflow and achieve production targets.

21. Conduct periodic aseptic media fill validations and periodic qualification of equipment as per the schedule.

22. Utilize computer applications to enter and interact with equipment data.

23. Demonstrate knowledge of production processes and workflow.

24. Read and understand technical documents and work orders.

25. Adhere to all safety measures and wear appropriate personal protective equipment (PPE) at all times.

26. Assist in training new operators on machinery operation and safety procedures.

27. Actively participate in team meetings and contribute suggestions for process improvements.

28. Monitor the consumable inventory and inform to supervisors of any shortages.

29. Follow standard operating procedures (SOPs) for all assigned tasks by the production supervisor.

30. Operate machinery and equipment efficiently within a production environment.

31. Maintain the work area accordance with safety and hygiene standards.

32. Ensure proper communication with supervisors and co-workers about ongoing production matters.

33. Conduct a proper shift handover before leaving the production area.

34. Participate in emergency response procedures and safety drills.

35. Observe and report any potential quality concerns or safety hazards to supervisors.

**OTHERS:**

- Ensure compliance with Environmental Health and Safety (EHS) norms at all times.

- Maintain compliance with cGMP (Current Good Manufacturing Practices) in all operations.

- Follow ALCOA+ principles.

- Uphold the highest level of data integrity consistently.

- Immediately escalate any abnormalities observed to the immediate supervisor or HR department.